The Cardica® PAS-Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS-Port® Proximal Anastomosis System consists of a connector and a delivery system.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This is a 510(k) summary for a medical device (PAS-Port® Proximal Anastomosis System) seeking substantial equivalence to a predicate device.

The document focuses on:

Device identification and categorization: Trade name, common name, classification, regulation number.
Predicate device: K081225.
Device description: How it works for aortic vein graft anastomosis.
Indications for Use: To create the aortic anastomosis of aortic autologous vein grafts.
Comparison to predicate device: Stating substantial equivalence and similarity in indications for use and technological characteristics.
Device Testing Results and Conclusion: A general statement that in vitro and in vivo testing was performed to ensure substantial equivalence, safety, and effectiveness. However, specific acceptance criteria, study designs, or actual performance metrics are not detailed.
FDA Clearance Letter: Confirming substantial equivalence based on the provided information.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set information. These details are typically part of a more extensive submission package to the FDA, not usually included in the public 510(k) summary.

Summary

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K091017 Pg 10f 2 PAS-Port® Proximal Anastomosis System

510(k) Summary

APR 2 9 2009

PAS-Port™ Proximal Anastomosis System

510(k) Number
Date Prepared	April 7, 2009
Applicant Information	900 SaginawRedwood City, California 94063Main: 650-364-9975Fax: 650-331-7195
Contact Person	Kimberlee LeonOffice: 650-331-7119Fax: 650-331-7195e-mail: leon@cardica.com
Establishment Registration Number	3004114958
Device Information	Classification Name: Clip, ImplantableRegulation Number: 21 CFR §878.4300Trade Name: Cardica® PAS-Port® Proximal Anastomosis SystemCommon Name: Cardiovascular Surgical Instruments
Legally Marketed Predicate Device(s)	PAS-Port® Proximal Anastomosis System (K081225)
Device Description	The Cardica® PAS-Port® Proximal Anastomosis System is amechanical device used to facilitate an aortic vein graftanastomosis. The connector replaces sutures to create asecure, patent and reproducible anastomosis. The PAS-Port®Proximal Anastomosis System consists of a connector and adelivery system.

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Indications for Use	The PAS-Port® System is intended to create the aorticanastomosis of aortic autologous vein grafts.
Comparison toPredicate Device	The PAS-Port® Proximal Anastomosis System is substantiallyequivalent to the PAS-Port® Proximal Anastomosis System(K081225, 21 CFR §878.4300).
Device TestingResults andConclusion	All necessary in vitro and in vivo testing has been performedon the PAS-Port® Proximal Anastomosis System and itspackaging to ensure substantial equivalence to the predicatedevice, and to ensure the safety and effectiveness of thedevice.
TechnologicalCharacteristics	See Device Description above.
SubstantialEquivalenceSummary	Both, the Cardica® PAS-Port® Proximal Anastomosis Systemhave the same indications for use and the same technologicalcharacteristics as the predicate device (K081225). Thispremarket notification has described the characteristics of themodified device in sufficient detail to assure substantialequivalence.
Conclusions	This Special 510(k) for Device Modification submission hasdemonstrated Substantial Equivalence as defined andunderstood in the Federal Food Drug and Cosmetic Act andvarious guidance documents issued by the Center for Devicesand Radiological Health.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2009

Cardica, Inc. c/o Ms. Kimberlee Leon Manager, Quality Systems 900 Saginaw Drive Redwood City, CA 94063

Re: K091017

Cardica® PAS-Port® Proximal Anastomosis System Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class II Product Code: FZP Dated: April 7, 2009 Received: April 9, 2009

Dear Ms. Leon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Kimberlee Leon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

R. becher

ABram D. Zuckerman, M.D. > Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K091017 PAS-Port® Proximal Anastomosis System

. Indications for Use Statement 510(k) Number: K091017 (if known) Cardica® PAS-Port® Proximal Anastomosis System Device Name: The Cardica® PAS-Port® Proximal Anastomosis System is intended to Indications for Use: create the aortic anastomosis of aortic autologous vein grafts.

Prescription Use X (Part 21 CFR§801.109)

Over-The-Counter Use OR (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dname R. Liciason
(Division Sign-Off)

Division of Cardiovascular Devices

H. Indications for Use Statement

510(k) Number Korano(7

Pg. 1 of 1

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.